A Randomized Controlled Study of Uterine Incision Diverticulum Repair vs. no Repair During Second/Third Cesarean Section

NCT06612957 | Not Yet Recruiting DMC

• 1 other identifier: 2024B06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to assess the efficacy and safety of uterine incision diverticulum repair during repeat cesarean section.The main questions it aims to answer are:

• Can this surgical method improve the symptom of menorrhagia？
• Is this procedure safe？ Researchers will compare experimental group(Cesarean section + diverticulum repair group) to control group(Conventional cesarean section group) to see if this surgical method works to treat or improve menorrhagia. Participants will:
• randomly assigned 1:1 to the experimental group（repairing uterine diverticula during cesarean section) and the control group （Routine cesarean section without repairing the uterine incision diverticulum）
• visit the hospital 42 days after surgery
• followed up by telephone 6-12 months after surgery

Conditions

Cesarean Scar Diverticulum

Outcome Measures

Primary Outcomes (1)

• Regularity of postpartum menstrual cycle

  Whether the symptoms of menorrhagia after cesarean section disappear or improve

  Six months after cesarean section

Study Arms (2)

Cesarean Section + Uterine Diverticulum Repair Group

EXPERIMENTAL

The original skin incision is used as the surgical incision. Tissues are sequentially separated until reaching the uterus. The original uterine incision'supper edge is used as the surgical incision for this procedure. The bladder is pushed down to fully expose the lower segment of the uterus. After the complete delivery of the fetus and placenta, the placental tissues are thoroughly cleaned, and the uterine scar diverticulum tissue in the lower segment is trimmed down to the original incision edge, making the lower edge of the incision normal uterine muscle tissue. The trimmed uterine scar diverticulum tissue is sent for pathological examination.

Procedure: Repair of uterine cicatricial diverticulum

Conventional Surgery Group

NO INTERVENTION

Participants randomly assigned to the control group undergo the same preoperative preparations and surgical procedures as the intervention group, except for the specific steps involving the repair of the uterine diverticulum.

Interventions

Repair of uterine cicatricial diverticulum PROCEDURE

Cut off the uterine cicatricial diverticular tissue in the lower portion of the uterus, and restore normal uterine muscle tissue.

Cesarean Section + Uterine Diverticulum Repair Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18 years, gestational age ≥37 weeks, singleton pregnancy, previous lower segment cesarean section, second or third cesarean section, and diagnosed with uterine incision diverticulum by imaging before or during early pregnancy.

You may not qualify if:

• Preoperative indications of placenta accreta or previa, interdelivery interval less than 18 months from the last cesarean section, history of other uterine surgeries, and severe obstetric or medical complications requiring emergency care.

Sponsors & Collaborators

• Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School: lead

Central Study Contacts

Zijun Wang, bachelor

CONTACT

+8618018590678; 18018590678@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior chief physician

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share